Emily is a Levonorgestrel releasing Intrauterine System indicated for Intrauterine contraception for up to 5 years and for the treatment of heavy menstrual bleeding.

Watch Emily Insertion and Placement video

About EMILY (Levonorgestrel releasing Intrauterine System)

BRIEF PRESCRIBING INFORMATION

This information does not include all details needed to use Emily safely and effectively. See full prescribing information for Emily. Emily (Levonorgestrel releasing Intrauterine System) Approval date (India): 2011
-Full Prescribing Information

INDICATIONS

Emily is a sterile, Levonorgestrel releasing Intrauterine System indicated for:

Intrauterine contraception for up to 5 years, in women who have at least one child.

Treatment of heavy menstrual bleeding for women who suffer from dysfunctional uterine bleeding and who are willing to accept LNG IUD as an alternative to hysterectomy or oral medications.

DOSAGE AND ADMINISTRATION

Release rate of Levonorgestrel is approximately 20 µg per day; Emily should be replaced after 5 years.

To be inserted by a trained healthcare provider using strict aseptic technique. Healthcare providers are advised to become thoroughly familiar with the insertion instructions before attempting insertion.

Patient should be re-examined and monitored 4 to 12 weeks after insertion; then, yearly or more often if indicated.

DOSAGE FORMS AND STRENGTHS

One sterile Intrauterine System consisting of M-shaped polyethylene frame with a steroid reservoir containing 52 mg Levonorgestrel held within an inserter tube.

WARNINGS AND PRECAUTIONS

If pregnancy occurs with Emily in place, remove Emily.

Increased risk of ectopic pregnancy

Group A streptococcal infection has been reported; strict aseptic technique is essential during insertion.

Before using Emily, consider the risks of PID.

Bleeding patterns become altered, may remain irregular and amenorrhea may ensue.

Perforation may occur during insertion. Risk is increased in women with fixed retroverted uteri, during lactation, and postpartum.

Embedment in the myometrium and partial or complete expulsion may occur.

FAQ

Frequently Asked Questions

EMILY is an intrauterine delivery system (IUS) consisting of a small white M-shaped frame made from soft, flexible plastic which releases small amounts of hormone Levenorgestrel locally into your uterus. Emily helps to prevent pregnancy for up to 5 years.
Emily can also lessen menstrual blood loss in women who have abnormal uterine bleeding and who also want to use a birth control method that is placed in the uterus to prevent pregnancy.

Emily is recommended for women who have had at least one child.

You can try to become pregnant as soon as Emily is removed by your healthcare provider.

It is not known exactly how Emily works. Emily may work in several ways. It may thicken your cervical mucus, thin the lining of your uterus, inhibit sperm movement and reduce sperm survival.
Emily may stop release of your egg from your ovary, but this is not the way it works in most cases. Most likely, these actions work together to prevent pregnancy. Emily can cause your menstrual bleeding to be less by thinning the lining of the uterus.

In a clinical study conducted on 45 patients, Emily has shown 93% efficacy in reducing menstrual bleeding in about 6 months. The published clinical study can be assessed below more information about Emily.
EMILY CLINICAL TRIAL PAPER

No, the insertion procedure usually takes a few minutes after your doctor has completed the pelvic examination. You will be protected from pregnancy as soon as insertion of the system is complete; however, it is best to wait 24 to 48 hours before having sexual intercourse. A reduction in menstrual blood loss should be apparent from the first menstrual cycle.

EMILY will affect your menstrual cycle. You might experience frequent spotting (a small amount of blood loss) or light bleeding in addition to your periods for the first 3 to 6 months. In some cases, you may have heavy or prolonged bleeding during this time. Overall, gradually, your menstrual period may disappear when using EMILY. Due to the hormone’s effect on the lining of the uterus it’s become thicken. Therefore there is little or no bleeding, as happens during a usual menstrual period. But, when the system is removed, periods should return to normal. Menstruation disappearance does not necessarily mean you have reached menopause or are pregnant. If, however, you are having regular menstrual periods and then do not have one for 6 weeks or longer, it is possible that you may be pregnant. You should consult with your doctor.

Pelvic inflammatory disease (PID). Some IUD users get a serious pelvic infection called pelvic inflammatory disease. PID is usually sexually transmitted. You have a higher chance of getting PID if you or your partner has sex with other partners. PID can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. PID is usually treated with antibiotics. More serious cases of PID may require surgery. A hysterectomy (removal of the uterus) is sometimes needed. In rare cases, infections that start as PID can even cause death. Tell your healthcare provider right away if you have any of these signs of PID: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal (stomach area) pain, painful sex, chills, or fever.

Embedment : Emily may become attached to the uterine wall. This is called embedment. If embedment happens, Emily may no longer prevent pregnancy and you may need surgery to have it removed.

Perforation : Emily may go through the uterus. This is called perforation. If your uterus is perforated, Emily may no longer prevent pregnancy. It may move outside the uterus and can cause internal Scarring, infection, or damage to other organs, and you may need surgery to have Emily removed.

During sexual intercourse, you or your partner should not be able to feel EMILY. If you can feel EMILY, or any pain or discomfort that you suspect may be caused by it, then you should not have sexual intercourse until you consult your doctor to verify it is still in the correct position.

No. Emily (Levonorgestrel-releasing Intrauterine System) does not protect against HIV or STDs. So, if while using Emily you should think you or your partner is at a risk of getting an STD, use a condom and call your healthcare provider.

Clinical Studies

The prospective, multicentre, single-arm, phase 4 study involved 45 patients with significant heavy menstrual bleeding. The patients were treated with Emily over a period of 6 months and the patients had shown significant reduction in heavy menstrual bleeding at the end of 6 months. The results are as follows;

About R & D

R & D Centre, Thiruvananthapuram, Kerala

Through the interchange of creative, imaginative people, a global Research and Development (R & D) centre that encourages collaboration and cooperation among highly reputed research centres in the country; and a strong commitment to ongoing investment, we have put R & D at the centre of everything we do.

From Blood Transfusion Bags to Hydrocephalus Shunts, once-a-week Non Steroidal Oral Contraceptive Pills and several variants of condoms, every product from HLL is a result of innovation.

The last four decades have seen HLL network with various scientific and academic institutions of excellence for developing novel healthcare products. HLL has a state-of-the-art R & D centre at Thiruvananthapuram in Kerala, India.

R & D Centre, Thiruvananthapuram, Kerala

HLL's R & D centre has several projects in hand, carried out in-house or on collaborative mode, with premier academic and research institutions in the country and abroad. These projects cover a wide area of research ranging from development of novel techniques for drug delivery to blood filters, novel contraceptives and cancer-care devices. Some of the institutions HLL has networked with are-Indian Institute of Technology (IIT), Kanpur; Central Drug Research Institute (CDRI), Lucknow; Sree Chitra Thirunal Institute of Medical Sciences & Technology (SCTIMST), Thiruvananthapuram; Regional Cancer Centre (RCC), Thiruvananthapuram, and Population Council, USA.

HLL has set up a Technology Business Incubation centre (TBlC) at Rajiv Gandhi centre for Biotechnology (RGCB), Thiruvananthapuram. The goal of the TBlC is to develop novel, fast and easy-to-use diagnostic methodologies for various infectious diseases. As part of this collaboration, HLL has developed a duplex kit for viral infections. This project would be extended to development of newer and less expensive diagnostic kits.

Based on its technological competency, the R & D centre is implementing sponsored projects from organisations including Department of Science and Technology (DST), Defense Research Development Organisation (DRDO), Department of Biotechnology (DBT), Council of Scientific Industrial Research (CSlR) and international agencies like Bill & Melinda Gates Foundation.

Uterus defines your Womanhood

Save the Uterus

Save your Womanhood

The status of Indian women has been subjected to many great changes over the past few decades. From equal status with men in ancient times, to equal rights in modern era, history of Indian Women has been really eventful. Today, Women have held high offices in India including President, Prime Minister, to jobs like flying an Aircraft to Business Management and Teaching etc.

But the fate of Indian Women still remains the same when it comes to Healthcare Sector. Despite, several advancements in Healthcare Sector, due to societal cum medical reasons, women are left with no choice but to lose their Womanhood to the hands of Hysterectomy.

Medical reasons for Hysterectomy (Removal of Uterus) vary. Major reason for Hysterectomy is Heavy Menstrual Bleeding, referred in medical terms as Dysfunctional Uterine Bleeding. Almost 40-50% of women in the age group of 40-45 suffer from the problem of heavy bleeding, accompanied with pain and discomfort. This condition is called Heavy Menstrual Bleeding. While most of these cases can be treated by using Medical options, their ineffectiveness in some cases makes the doctors advise Hysterectomy.

In some parts of our country, post completion of the family, uterus is viewed as an unwanted organ. Women approach doctors for uterus removal. While this practice is unwarranted, uterus removal has many complications like increased risk of osteoporosis and heart diseases.

While more and more of Women, post family completion, are opting to remove the uterus to get rid of this indication, Doctors across the Globe have been advocating against the removal of uterus.As per recent data available, every year 40 Lac Indian women undergo Hysterectomy and lose their uterus. While a number of options are available to prevent Hysterectomy, Indian women have been deprived of the same.

“Save the Uterus”, is an initiative by HLL Lifecare Limited (A Govt. of India Enterprise) to educate Indian women about complications involved post Hysterectomy and benefits of preserving their womanhood.

Here are few Frequently Asked Questions, by women who suffer from Heavy Menstrual Bleeding;

What is Heavy Menstrual Bleeding? How will I know if I am suffering from it?

Heavy menstrual bleeding is defined as losing more than 80ml of blood over the course of a menstruation cycle.

You may be suffering from HMB if you are using more number of sanitary pads than normal, pass blood clots or are flooding with sudden heavy loss.

My doctor has prescribed me some medicine, but still I am suffering from Heavy Menstrual Bleeding. Should I undergo Hysterectomy?

Medicines are prescribed by doctor as a first line of treatment in Management of Heavy Menstrual Bleeding. However, if these medications fail to provide you relief, Hormonal Intra-Uterine Systems (like EMILY) are suggested to treat to Indication.

IUS are one of the most effective and economical alternative to hysterectomy in most cases of Heavy Menstrual Bleeding.

With marked reduction in Blood loss, they improve the quality of life by reducing the pain associated with bleeding.

Studies suggest that 70% of hysterectomies cases can be prevented using Hormonal-Intra Uterine Systems

I want to “Save my Uterus”. How will I get a Hormonal Intra-Uterine System?

Hormonal Intra-Uterine systems are devices which are inserted in body by a doctor only.

For insertion of an IUS, please refer to your doctor for Hormonal IUS (EMILY)

For more information on Hormonal Intra-Uterine Systems, please visit www.emily.org.in